Cleared Traditional

K953434 - MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS) (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K953434 · Midas Rex Pneumatic Tools, Inc. · Neurology device
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May 1996
Decision
300d
Days
Class 2
Risk

K953434 is an FDA 510(k) clearance for the MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS). Classified as Motor, Drill, Pneumatic (product code HBB), Class II - Special Controls.

Submitted by Midas Rex Pneumatic Tools, Inc. (Fort Worth, US). The FDA issued a Cleared decision on May 16, 1996 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4370 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Midas Rex Pneumatic Tools, Inc. devices

Submission Details

510(k) Number K953434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1995
Decision Date May 16, 1996
Days to Decision 300 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 148d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBB Motor, Drill, Pneumatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4370
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.